Docusate

Docusate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Docusate is a OTC Laxative that is FDA approved for the treatment of constipation. Common adverse reactions include Stomach pain, diarrhea, or cramping.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• For the relief of occasional constipation due to hard stools. The effect on stools is usually apparent 1 to 3 days after the first dose.

Dosage

• As directed by a physician or once daily as follows: Adults and children 12 years of age and over: oral dosage is 5 to 20 mL (1 to 4 teaspoonfuls). Children 6 to under 12 years of age: oral dosage is 5 to 10 mL (1 to 2 teaspoonfuls). Children 3 to under 6 years of age: oral dosage is 2.5 to 5 mL (1⁄2 to 1 teaspoonful). Children under 3 years of age: consult a physician. The higher doses are recommended for initial therapy. Dosage should be adjusted to individual response. If desired, the product may be administered in a 6 to 8 oz glass of milk or fruit juice or in infant formula to mask the bitter taste.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Docusate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Docusate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Dosage

As directed by a physician or once daily as follows: Adults and children 12 years of age and over: oral dosage is 5 to 20 mL (1 to 4 teaspoonfuls). Children 6 to under 12 years of age: oral dosage is 5 to 10 mL (1 to 2 teaspoonfuls). Children 3 to under 6 years of age: oral dosage is 2.5 to 5 mL (1⁄2 to 1 teaspoonful). Children under 3 years of age: consult a physician. The higher doses are recommended for initial therapy. Dosage should be adjusted to individual response. If desired, the product may be administered in a 6 to 8 oz glass of milk or fruit juice or in infant formula to mask the bitter taste.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Docusate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Docusate in pediatric patients.

Contraindications

• Condition1

Warnings

Do not use laxative products when abdominal pain, nausea, or vomiting are present, or use for a period longer than 1 week, unless directed by a physician. If you have noticed a sudden change in bowel habits that persists over a period of 2 weeks, consult a physician before using a laxative. Rectal bleeding or failure to have a bowel move- ment after the use of a laxative may indicate a serious condition. Discontinue use and consult your physician. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. May cause rash in some cases.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Adverse Reactions

Clinical Trials Experience

Stomach pain, diarrhea, or cramping

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Docusate in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Do not take this product if you are presently taking mineral oil or a prescription drug, unless directed by a physician.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Docusate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Docusate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Docusate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Docusate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Docusate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Docusate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Docusate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Docusate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Docusate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Docusate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Docusate in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

Monitoring

There is limited information regarding Monitoring of Docusate in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Docusate in the drug label.

Overdosage

There is limited information regarding Overdose of Docusate in the drug label.

Pharmacology

There is limited information regarding Docusate Pharmacology in the drug label.

Mechanism of Action

Structure

• Each 5 mL (teaspoonful) contains docusate sodium 50 mg.

Inactive Ingredients

Citric acid, D&C Red No. 33, flavoring, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, and sorbitol.

Sodium Content: 14 mg/5 mL.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Docusate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Docusate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Docusate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Docusate in the drug label.

How Supplied

Storage

Keep tightly closed. Store at controlled room temperature, 20° to 25°C (68° to 77°F). Protect from freezing. Protect from light.

Images

Drug Images

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Package and Label Display Panel

PRINCIPAL DISPLAY PANEL Docusate Sodium Liquid

100 mg/ 10mL

Stool Softener Laxative

5 Cups

This image is provided by the National Library of Medicine.

Ingredients and Appearance

This image is provided by the National Library of Medicine.

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Docusate in the drug label.

Precautions with Alcohol

• Alcohol-Docusate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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